Pramipexole dihydrochloride

What Pramipexole dihydrochloride is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of: Parkinson's disease (PD) Moderate-to-severe primary Restless Legs Syndrome (RLS) 1.1 Parkinson’s Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. …

— FDA label: Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited; it covers 6 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 37 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 37 FDA labels for this medicine have a boxed warning.

Pramipexole dihydrochloride side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Most common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations (6.1) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency (6.1) RLS: nausea, somnolence, fatigue, and headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatc h.

Read more of this section

The following adverse reactions are discussed in greater detail in other sections of the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1)]. Symptomatic Orthostatic Hypotension [see Warnings and Precautions (5.2)]. Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.3)]. Hallucinations and Psychotic-like Behavior [see Warnings and Precautions (5.4)]. Dyskinesia [see Warnings and Precautions (5.5)]. Postural Deformity [see Warnings and Precautions (5.6)]. Rhabdomyolysis [see Warnings and Precautions (5.8)]. Retinal Pathology [see Warnings and Precautions (5.9)]. Events Reported with Dopaminergic Therapy [see Warnings and Precautions (5.10)]. Withdrawal Symptoms [see Warnings and Precautions (5.11)]. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Parkinson's Disease During the premarketing development of pramipexole, patients with either early or advanced Parkinson's disease were enrolled in clinical trials. Apart from the severity and duration of their disease, the two populations differed in their use of concomitant levodopa therapy. Patients with early disease did not receive concomitant levodopa therapy during treatment with pramipexole; those with advanced Parkinson's disease all received concomitant levodopa treatment. Because these two populations may have differential risks for various adverse reactions, this section will, in general, present adverse-reaction data for these two populations separately. Because the controlled trials performed during premarketing development all used a titration design, with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse reactions. Early Parkinson's Disease In the three double-blind, placebo-controlled trials of patients with early Parkinson's disease, the most common adverse reactions (>5%) that were numerically more frequent in the group treated with pramipexole dihydrochloride tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations. Approximately 12% of 388 patients with early Parkinson's disease and treated with pramipexole dihydrochloride tablets who participated in the double-blind, placebo-controlled trials discontinued treatment due to adverse reactions compared with 11% of 235 patients who received placebo.

— FDA label: Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026. This is part of the section. Read the full label on DailyMed →

Pramipexole dihydrochloride drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Dopamine antagonists: May diminish the effectiveness of pramipexole (7.1) 7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride tablets.

— FDA label: Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026. Read the full label on DailyMed →

Pramipexole dihydrochloride dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Parkinson's Disease-Normal Renal Function* (2.2) Week Dosage (mg) Total Daily Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.5 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.5 * Doses should not be increased more frequently than every 5 to 7 days. Titrate to effective dose. If used with levodopa, may need to reduce levodopa dose.

Read more of this section

Parkinson's Disease-Impaired Renal Function (2.2) Creatinine Clearance Starting Dose (mg) Maximum Dose (mg) > 50 mL/min 0.125 TID 1.5 TID 30 to 50 mL/min 0.125 BID 0.75 TID 15 to 30 mL/min 0.125 QD 1.5 QD < 15 mL/min and hemodialysis patients Data not available Restless Legs Syndrome* (2.3) Titration Step Dose (mg) 2 to 3 hours before bedtime 1 0.125 2 (if needed) 0.25 3 (if needed) 0.5 * Dosing interval is 4 to 7 days (14 days in patients with CrCl 20 to 60 mL/min) 2.1 General Dosing Considerations Pramipexole dihydrochloride tablets are taken orally, with or without food. If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted. 2.2 Dosing for Parkinson's Disease In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth. Dosing in Patients with Normal Renal Function Initial Treatment Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1: Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 three times a day 0.375 2 0.25 three times a day 0.75 3 0.5 three times a day 1.50 4 0.75 three times a day 2.25 5 1 three times a day 3.0 6 1.25 three times a day 3.75 7 1.5 three times a day 4.50 Maintenance Treatment Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day). In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.

— FDA label: Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026. This is part of the section. Read the full label on DailyMed →

Pramipexole dihydrochloride in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. Effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see Data].

Read more of this section

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. This increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not in rabbits or humans. Because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. The highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (AUC) approximately equal to those in humans receiving the maximum recommended human dose (MRHD) of 4.5 mg/day. There were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, or 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma AUC up to approximately 70 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. The no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the MRHD.

— FDA label: Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026. Read the full label on DailyMed →

Pramipexole dihydrochloride overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

There is no clinical experience with significant overdosage. One patient took 11 mg/day of pramipexole for 2 days in a clinical trial for an investigational use. Blood pressure remained stable although pulse rate increased to between 100 and 120 beats/minute. No other adverse reactions were reported related to the increased dose. There is no known antidote for overdosage of a dopamine agonist.

Read more of this section

If signs of central nervous system stimulation are present, a phenothiazine or other butyrophenone neuroleptic agent may be indicated; the efficacy of such drugs in reversing the effects of overdosage has not been assessed. Management of overdose may require general supportive measures along with gastric lavage, intravenous fluids, and electrocardiogram monitoring.

— FDA label: Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Alembic Pharmaceuticals Limited17 products
• Macleods Pharmaceuticals Limited12 products
• Alembic Pharmaceuticals Inc.12 products
• Bryant Ranch Prepack10 products
• Ingenus Pharmaceuticals, LLC7 products
• Torrent Pharmaceuticals Limited6 products
• Unichem Pharmaceuticals (USA), Inc.6 products
• Aurobindo Pharma Limited6 products
• Glenmark Pharmaceuticals Inc., USA6 products
• NorthStar RxLLC6 products
• Golden State Medical Supply, Inc.6 products
• Camber Pharmaceuticals, Inc.6 products
• Rising Pharma Holdings, Inc.6 products
• Strides Pharma Science Limited6 products
• ScieGen Pharmaceuticals, Inc.6 products
• Dr. Reddy's Laboratories Limited5 products
• A-S Medication Solutions4 products
• American Health Packaging3 products
• NCS HealthCare of KY, LLC dba Vangard Labs2 products
• Xiamen LP Pharmaceutical Co., Ltd.2 products
• Vitruvias Therapeutics, Inc.2 products
• Major Pharmaceuticals1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (13)

• ANDA078894Alembic · October 8, 2010
• ANDA090781Glenmark Pharms Ltd · October 8, 2010
• ANDA090865Torrent Pharms · October 8, 2010
• ANDA202164Macleods Pharms Ltd · September 20, 2012
• ANDA202633Aurobindo Pharma Ltd · October 26, 2012
• ANDA202702Strides Pharma · June 3, 2014
• ANDA203855Sciegen Pharms · October 28, 2014
• ANDA203354DR Reddys · August 7, 2015
• ANDA206156Macleods Pharms · June 24, 2016
• ANDA207011Unichem · December 19, 2018
• ANDA204518Alembic · January 2, 2019
• ANDA212797Xiamen LP Pharm Co · June 11, 2021
• ANDA213444Novast Labs · February 3, 2022

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. August 21, 2019 · Class III · Terminated · D-1851-2019

   Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

   Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33 — Macleods Pharma Usa Inc

2. December 24, 2015 · Class II · Terminated · D-0653-2016

   Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

   Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC — Macleods Pharma Usa Inc

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Parkinson's diseaseCondition named on the label: hospitals that treat it
• Alembic Pharmaceuticals LimitedMaker or distributor
• Macleods Pharmaceuticals LimitedMaker or distributor
• Alembic Pharmaceuticals Inc.Maker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Pramipexole Dihydrochloride, Torrent Pharmaceuticals Limited, effective March 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers